In 1790, while Samuel Hahnemann was translating a materia medica from English into German, he came across a reference that the prevalent prescription for malaria at that time was cinchona bark. The reason stated for its efficacy was that it was quite bitter. Dr. Hahnemann was well versed in the current use of medicine and felt that there must be another reason besides its bitter qualities that made it work because many other medicines were bitter but ineffective in the treatment of malaria. By experimenting on himself, through taking cinchona bark and observing the effects he was able to produce the symptoms of malaria: chills, fever, palpitations, and sweats. These observations were included in his translated text as a footnote.
The more Hahnemann studied and translated medicine and medical texts, the clearer it became to him that if healthy people took massive amounts of a particular drug, the drug would actually cause the same symptoms it was supposed to cure. Hahnemann then reasoned that the symptoms of a sick patient could be matched to symptoms that a drug produced. His experiments along the lines of his reasoning lead to the development of a new branch of medicine, which he called homeopathy, from the Latin words, homeo, meaning the same, and pathos, meaning illness.
In order to demonstrate the effectiveness of a homeopathic drug, the drug is tested by a “proving” in order to see how the drug will effect an otherwise healthy person. Hundreds of compounds have been tested according to such “proving”. Homeopathic repertories provide listings of the human anatomy and set forth symptoms that have been observed on such body part and treatments for the symptoms. On the other hand, books referred to as “Materia Medicae” set forth the homeopathic drugs and identify the maladies and symptoms each drug treats. Moreover, where a repertory lists a symptom, it classifies possible treating compounds as either first, second or third degree remedies for that symptom. Typically, a homeopathic practitioner will prescribe first degree indications for a particular symptom although sometimes second indications may be employed on a case-by-case basis. Very seldom would a homeopathic practitioner think to use a third degree indication and such listings are provided only to note that, on rare occasions, that the remedy has been known to cure the symptom but that it is not recognized by a “proving”.
The current materia medicas have up to 5,000 proven drugs listed. The drugs are derived from plants, minerals and animal substances. The remedies are listed in alphabetical order in the materia medica. The materia medica has grown to include not just symptoms that were proven but also to include toxicological symptoms as well as symptoms that were actually cured in sick patients using that particular remedy. The symptoms in the materia medica are categorized in order from the top of the body on down. So all the symptoms in the head are categorized together, then the eyes, ears, nose and so on until the extremities.
Some remedies have only 40 symptoms listed in the materia medica, while others have 15,000 symptoms. Since it is impossible to remember all the symptoms of each remedy, about 150 years ago the information was collated into a reference form. All the remedies that affect a certain place in a certain way were placed under a particular category. The book that contained these categories is called a repertory. The categories listed in the repertory are called rubrics.
The repertory of the materia medica is actually a reference tool that lists all the symptoms cured or produced and list every remedy that has treated that particular category/rubric. For example, a rubric might list: Head: pain, above left eye, 3 pm lasting to 6 pm, with one remedy listed under the rubric. Rubrics can be very specific like this one, or very general. A general rubric would be Head; pain, and that general rubric would contain hundreds and hundreds of remedies. The more specific the rubric the better for a homeopath, as it truly indicates a closer match. However, specific rubrics are likely to be too specific and incomplete and therefore misleading.
Hugo Schultz, in 1887, postulated that the effect of a stimulus on a living cell is indirect and proportional to its intensity and quantity. Schultz demonstrated that very low concentrations of yeast toxins increased yeast growth over 100 fold. Around the same time, the psychiatrist Rudolph Arndt developed his “Basic Law of Biology,” which states that weak stimuli slightly accelerate the vital activity, middle-strong stimuli raise it, strong stimuli suppresses it, and very strong stimuli halt vital activity. These separate observations were formulated by Arndt in 1888 into one of the earliest laws of pharmacology representing the homeopathic effect, the Arndt-Schultz law, which states: every stimulus on a living cell elicits an activity, which is inversely proportional to the intensity of the stimulus (Martius F. Das Arndt-Schultz Gnindgesetz, Muench Med. Wschr., 1923, 70(31):1005-1006). This law was later restated by Hueppe as: for every substance, small doses stimulate, moderate doses inhibit, large doses kill. Allopathic medicine, with its emphasis on moderate to high drug doses, works to inhibit undesired physical symptoms and to kill undesired pathogens. Homeopathic medicine begins with small doses and moves towards higher and higher dilutions to stimulate the body's own natural defenses.
One of the basic tenets of homeopathic medicine is that a cure for a disease can be evoked by using a high dilution medicine that resembles but is different from the cause of the disease. Homeopathy is widely accepted as a useful therapeutic throughout Europe, the British Commonwealth countries and India, and has been demonstrated to have characteristic and reproducible effects. A critical review of more than 100 controlled and/or clinical studies of homeopathy determined that patients received positive healing benefits from homeopathy beyond the placebo effect (Kleijnen, J. et al. 1991 Brit. Med. J. 302:316-323; Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F., Hedges, L. V., Jonas, W. B., 1997, Lancet, 350:834-843; Reilly, D., et al, 1994, Lancet, 344:1601-1608).
After a base preparation is made, either by an extract or maceration of an herbal compound or the dissolving of a selected compound in a solvent, a series of dilutions are prepared from the initial batch, called the “mother tincture”. Homeopathic drugs are diluted according to either the decimal “X” or centesimal “C” scales. For a “3X” preparation, the mother tincture is diluted with nine parts of the desired diluent, in either liquid or powder form. The resultant mixture is then diluted a second time, in a ratio of one part mixture to ten parts solvent and the resulting mixture is diluted a third time in a ration of one to ten. Therefore, the 3X drug is actually at 10−3 potency of the mother tincture. Similarly, a 6X dilution would be at 10−6 potency of the original solution. In the “C scale” each dilution is done with ninety-nine parts diluent to the original mixture. Therefore, a 3C solution is at 10−6 potency of the original mixture and thus corresponds to a 6X potency. These scales are recognized by the Homeopathic Pharmacopeia of the United States (H.P.U.S.).
Many homeopathic medicines are used at concentrations of micrograms (10−6 M) and nanograms (10−12 M); however, in other homeopathic preparations, the dilutions exceed Avogadro's number (6.023×10−23). When compounds are diluted 1:10 (or 1:100), with repeated succusions (violent shaking or pounding) and repetitively diluted by this procedure these compounds are prepared and labeled as homeopathic remedies. A variety of dilution or attenuation methods are known in the art, the most common methods are the Hannemannina and the Korsakovian methods. If a dilution has been repeated at least 24 times, a potency is achieved (10−24) that is so highly dilute that the statistical probability of a single molecule of the original substance remaining in the volume used is low. Homeopathic practitioners believe that the original molecules effect a change in the solvent and that each successive dilution further increases both this change and the potency of the remedy regardless of the presence of molecules of the original material in much the same manner as bronze casting reproduces an original sculpture made of wax or clay with the need for wax or clay in the final sculpture. In traditional homeopathic practice, a frequent homeopathic dosage is 10-15 drops of a 10−12 molar, or 6 C, solution administered two to three times per day. A 10−60 molar or 30 C may be given one to three times per day. A 10−400 molar or 200 C may be given only one time per month or year. The beneficial activity of such highly diluted remedies are derived exclusively from the changes in the energy field or the solvent of the remedy caused by the original molecules. Scientific researchers at Harvard University have reported that changes in NMR spectra of the solvent occur as a result of this process.
In contrast many homeopathic medicines, especially combination products and those sold OTC, have dilutions between 2× and 24×. Especially those at dilutions between 3× and 10× have very substantial number of molecules and thus their beneficial effects are a summation of the physical chemical effects of the molecules plus the energy and enhanced solvent effects. This invention applies equally to these low dilutions and to the super molecular dilutions described above. For general use the preparations with significant number of molecules remaining 2× to 20× are a preferred embodiment of this invention.
A scientific discipline called “hormesis” has recently received increasing acceptance. This field documents that low doses of otherwise toxic materials are not toxic and may produce ill defined but clearly beneficial effects. This phenomenon has not previously been used therapeutically. One aspect of this invention is that doses labeled hormetic are not only not toxic but may be used in a therapeutic manner. The dose range that this phenomenon occurs is below that of standard pharmaceutical or toxicological effects. It is often but not necessarily above the dose used in homeopathic medicine. The scientific principle behind it is akin to the principle of homeopathy. Although these preparations may not be prepared by the classical methods of homeopathic pharmacists they are included in the definition of homeopathic preparations for the purpose of this invention.
Analogous to chemical homeopathy/hormesis it has been found that, contrary to the accepted views on radiation, that low doses of radiation (including that given off by radon) are not harmful. One aspect of this invention is that low doses of radiation defined herein as a homeopathic dose of radiation is prophylactic and therapeutic.
Highly dilute homeopathic medicines have been effective in treating some conditions, including viral infections, in vivo. For example, homeopathic dilutions of 1×10−200 to 1×10−1000 of typhoidinum, hydrophobinum, tuberculinum, nux vomica and malandrinum caused 100% inhibition of pock-like lesions caused by a chicken embryo DNA virus on the chorio-allantoic membrane as compared to controls (Singh, L. M. and Gupta, G. 1985 Brit. Homeopathy 74:168-174). In contrast, the same medicines at different homeopathic concentrations, or control phosphate buffered solution (PBS), had lesser or no effect.
A common principle of homeopathy is the Law of Similars, which was founded in the science of pharmacology and states that a drug has two effects on the body, a direct effect and the subsequent reaction of the body to the drug, evoking symptoms or side effects. This approach follows a rule that, where a substance produces a specified disease symptom or indication at a high dosage level in a healthy person, that symptom will be effectively treated in an ill person by a substantially dilute dose of the same substance. In other words, a symptom of a disease may be treated by a minor amount of a compound that will cause such symptom in a healthy person when administered at greater levels. The U.S. FDA defines homeopathy as “the practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects.” The U.S. FDA accepts as a homeopathic drug “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it or its supplements. The potencies of homeopathic drugs are specified in terms of dilution, i.e., 1× 1/10 dilution, 2× 1/100 dilution, etc. Homeopathic drug products must contain diluents commonly used in homeopathic pharmaceutics. Homeopathic drugs are for the most part, natural substances, although synthetic substances can be used. They are distributed as over the counter, through mass distribution channels without physician prescription, or as prescription, through highly controlled channels requiring physician prescription. The operative principals for homeopathic drugs are to utilize very low concentrations of drug, generally well below the Minimum Toxic Dose (MTD) for humans, and to manufacture them in a certain way with certain materials generally by a series of dilution steps with a defined process of vigorous agitation, termed succussion, between each step. Homeopathic drugs, due to their low concentrations. Homeopathic OTC drugs, in particular, are considered very safe and thus distributed through mass market channels. Homeopathic OTCs are ubiquitous and readily available to the general populace via the same or similar channels as vitamins, foods and nutritional supplements. Other drugs, sometimes known as standard drugs, allopathic drugs or ethical pharmaceuticals, are natural or synthetic substances usually presented for use at high concentrations much nearer the potentially toxic level. Allopathic drugs thought to be safe for the general population may also be categorized as over the counter and may be distributed through mass distribution channels without physician prescription. Allopathic drugs, when available by prescription, are distributed through highly controlled channels requiring physician prescription. Allopathic drugs are manufactured under strict methods and utilize materials that are specific to each drug. Thus, the distribution of allopathic drugs is very controlled and they are not readily available to the general populace.
The U.S. FDA specifies a dietary supplement product may make no statements on the effect it has on the structure or function of the body as distinguished from drug claims that a product diagnoses, treats, prevents, cures, or mitigates disease. Dietary supplements should be presented at concentrations very far away from their toxic doses; they are distributed through mass market channels, are ubiquitous and readily available to the general populace, similar to vitamins and foods.
Table 1 is a comparison of the toxic doses for various classes of ingestible compounds and shows the relationship of the above compounds with their toxic doses.
TOXIC DOSE COMPARISONIngestible CompoundToxic Dose LevelEthical Pharmaceutical0.1–0.5toxic dose levelOTC Drug0.1–0.3toxic dose levelDietary Supplement0.001–01toxic dose levelHomeopathic Medicine<0.000001toxic does level
Because homeopathic drugs are at very low concentration levels, far from their toxic dose they are very safe. This safety reduces the need to establish a detailed, extensive body of scientific evidence that presents their disease performance characteristics. As a result there is considerably less detailed information for homeopathic drugs versus other drugs. Additionally, contributing to the limited scientific evidence for homeopathic drugs, is the fact that homeopathy has been known and used for hundreds of years reducing the need and arguing against the expense to perform detailed modern scientific and clinical trials. Another reason for reduced scientific information for homeopathic drugs is the process to present a homeopathic drug to the user follows a shorter and less costly regulatory approval process versus allopathic drugs. As a consequence, the performance characteristics and benefits of homeopathic drugs are not nearly as well known to the caregiver and patient communities as are other drugs. In fact, one fundamental tenant of homeopathy is that each patient is an individual. The ideal remedy for one patient is thus likely to be counterproductive for another. Homeopathic physicians use their skill in evaluating individual patients to choose appropriate remedies. As the remedies are not toxic initial use may be considered a therapeutic trial and the physician will adjust the remedy and dose dependent on the clinical results seen in that patient. Population statistics are of no or limited value to homeopathic physicians or individual patients. Homeopaths believe that most patients are not approximated by an average or median, i.e. size M does not fit all.
Allopathic drugs, as a result of their high concentrations near toxic levels, are required to have extensive scientific evidence of safety and efficacy before they are presented for use. The cost and time to develop allopathic drug's scientific evidence to satisfy the regulatory approval process are much greater than the cost and time for homeopathic drugs.
Because Dietary Supplements are so very far away from their MTD and because they make no disease claims, the need to establish a detailed, extensive body of scientific evidence that presents their performance is nonexistent. While they fall under regulatory control, the regulatory requirements in dietary supplements are limited mainly to the primary compliance with truth in advertising requirements only. This approval process requires statistical documentation of statistical likelihood of success before a drug may be sold. Nevertheless therapy is individualized for each person and successful therapy of most all chronic diseases requires numerous drug and dosage adjustments for that patient. Genomics is the current term allopathic medicine is using to justify unique treatment of individuals, a position analogous to that traditionally used by homeopaths.
There is a great need for drugs that are very safe as a result of low concentrations, which are given at concentrations far from their toxic level and that frequently result in benefits to the patients. These drugs are defined by scientific evidence of characteristics and benefits based on disease performance similar to allopathic drugs and are readily available through mass distribution channels similar to foods or nutritional supplements. Such low concentration/high potency/scientific evidence based/mass distribution channel drugs are more effective because their scientific evidence of performance and benefits is based on disease experience and claims which allow users to make better decisions and achieve healthier life status.